GM Crop Database

Database Product Description

BT11 x GA21 (SYN-BTØ11-1 x MON-ØØØ21-9)
Host Organism
Zea mays (Maize)
Trait

Herbicide tolerant, glufosinate ammonium; Herbicide tolerant,glyphosate; Insect resistant, Lepidoptera.

Trait Introduction
Traditional plant breeding and selection
Proposed Use

Production for human consumption and livestock feed.

Product Developer
Syngenta Seeds, Inc.

Summary of Regulatory Approvals

Country Food Feed Environment Notes
Argentina 2009 2009 2009
Brazil 2009 2009 2009
Canada 2005 View
Colombia 2012 2010
European Union 2010 2010
Japan 2007 2007 2007
Korea 2006 2008
Mexico 2007 2007
Paraguay 2015 2015 2015
Philippines 2007 2007 2015
South Africa 2011 2011 2010
Taiwan 2009
Turkey 2011
Uruguay 2011 2011 2011

Introduction Expand

This stacked maize hybrid is a product of traditional plant breeding, and is therefore not automatically subject to regulation in all countries, unlike transgenic plants resulting from recombinant-DNA technologies. The approvals table above does not include entries from these countries. Other countries may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment, and these countries’ decisions are reflected in the approvals table.

The stacked hybrid BT11 X GA21 expresses three novel proteins: the delta-endotoxin Cry1Ab which confers resistance to the European Corn Borer and other lepidopterans, the PAT protein which confers tolerance to the herbicide glufosinate ammonium, and a modified EPSPS protein which confers tolerance to the herbicide glyphosate. The modified EPSPS protein is produced by the mepsps gene from GA21, the insecticidal protein Cry1Ab is produced by the cry1Ab gene and PAT is produced by the pat gene, both from BT11. The novel traits of each parental line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parental line please refer to the individual product descriptions in the crop database for BT11 and GA21.

The inserted genes and their gene products have a history of safe use, and have undergone review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in the stacked hybrid. The Cry1Ab protein is not an enzyme and therefore does not affect plant metabolism. PAT has a high affinity for L-Phosphinothricin, the active ingredient in glufosinate ammonium. The modified EPSPS has high affinity for its substrates phosphoenolpyruvate (PEP) and shikimate-3-phosphate, which are part of the shikimate metabolic pathway. PAT, EPSPS and Cry1Ab are therefore not expected to interact within, nor affect the metabolism of the stacked hybrid.

Summary of Introduced Genetic Elements Expand

Code Name Type Promoter, other Terminator Copies Form
cry1Ab Cry1Ab delta-endotoxin IR

CaMV 35S

IVS 6 intron from the maize alcohol dehydrogenase gene

A. tumefaciens nopaline synthase (nos) 3'-untranslated region

1

Truncated, modified

pat phosphinothricin N-acetyltransferase HT CaMV 35S IVS 2 intron from the maize alcohol dehydrogenase gene A. tumefaciens nopaline synthase (nos) 3'-untranslated region 1 Modified for enhanced expression
epsps 5-enolpyruvylshikimate-3-phosphate synthase HT

rice actin I promoter and intron sequences

ribulose-1,5-bisphosphate carboxylase oxygenase (RuBisCo) derived chloroplast transit peptide squences (from corn & sunflower)

A. tumefaciens nopaline synthase (nos) 3'-untranslated region

3*

Modified by in vitro mutagenesis; single insertion site with 3 complete copies of EPSPS cassette plus 3 incomplete copies

Characteristics of Zea mays (Maize) Expand

Center of Origin Reproduction Toxins Allergenicity

Mesoamerican region, now Mexico and Central America

Cross-pollination via wind-borne pollen is limited, pollen viability is about 30 minutes. Hybridization reported with teosinte species and rarely with members of the genus Tripsacum.

No endogenous toxins or significant levels of antinutritional factors.

Although some reported cases of maize allergy, protein(s) responsible have not been identified.

Donor Organism Characteristics Expand

Latin Name Gene Pathogenicity
Bacillus thuringiensis subsp. kurstaki EC2.4.2.19

While target insects are susceptible to oral doses of Bt proteins, no evidence of toxic effects in laboratory mammals or birds given up to 10 µg protein/g body weight.

Streptomyces viridochromogenes pat

S. viridochromogenes is ubiquitous in the soil. It exhibits very slight antimicrobial activity, is inhibited by streptomycin, and there have been no reports of adverse affects on humans, animals, or plants.

Abstract Collapse

BT11 X GA21 10 (OECD identifier: SYN-BTØ11-1 x MON-ØØØ21-9) maize is an F1 hybrid resulting from the hybridization of the lepidoteran-resistant and herbicide-tolerant maize line BT11 (SYN-BTØ11-1) and the herbicide-tolerant maize line GA21 (MON-ØØØ21-9). This stacked maize hybrid is a product of traditional plant breeding, and therefore is not automatically subject to regulation in all jurisdictions as are transgenic plants resulting from recombinant DNA technologies. Certain jurisdictions may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment. Examples of jurisdictions that require either notification or information about stacked hybrids prior to their release into the environment, and for use in human food and livestock feed are Japan and Korea.

The stacked hybrid BT11 X GA21 expresses three novel proteins: the delta-endotoxin Cry1Ab which confers resistance to the European Corn Borer and other lepidopterans, the PAT protein which confers tolerance to the herbicide glufosinate ammonium, and a modified EPSPS protein which confers tolerance to the herbicide glyphosate. The modified EPSPS protein is produced by the mepsps gene from GA21, the insecticidal protein Cry1Ab is produced by the cry1Ab gene and PAT is produced by the pat gene, both from BT11. The novel traits of each parental line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parental line please refer to the individual product descriptions in the crop database for BT11 and GA21.

The inserted genes and their gene products have a history of safe use, and have undergone review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in the stacked hybrid. The Cry1Ab protein is not an enzyme and therefore does not affect plant metabolism. PAT has a high affinity for L-Phosphinothricin, the active ingredient in glufosinate ammonium. The modified EPSPS has high affinity for its substrates phosphoenolpyruvate (PEP) and shikimate-3-phosphate, which are part of the shikimate metabolic pathway. PAT, EPSPS and Cry1Ab are therefore not expected to interact within, nor affect the metabolism of the stacked hybrid.

Links to Further Information Expand

Comissão Técnica Nacional de Biossegurança - CTNBio (Brazil) European Food Safety Authority (EFSA) Instituto Colombiano Agropecuario ICA Japanese Biosafety Clearing House, Ministry of Environment Mexican Health Secretary, Federal Commission for the Protection against Sanitary Risk Ministerio de Agricultura, Ganaderia y Pesca (Brasil) Ministerio de Salud Proteccion Social (Colombia) Ministry of Agriculture,Forestry and Fisheries of Japan Turkish Ministry of Food, Agriculture and Livestock, General Directorate of Agricultural Research and Policies Uruguay Gabinete Nacional de Bioseguridad (GNBio)

This record was last modified on Friday, February 24, 2017